Contract Organizations (CRO) Quality Control & Assurance

When it comes to regulatory compliance, contract organization (CRO) quality assurance depends on how closely an organization can align action and required regulatory standards. Contract manufacturers, testing laboratories, and research organizations (CxOs) face the same challenges as the pharmaceutical and medical device companies they serve. CxOs must comply with GxP requirements found in 21 CFR Parts 210-211 (pharmaceuticals), 21 CFR Part 820 (medical devices), and 21 CFR Part 11 (electronic records and electronic signatures). Organizations contracted by medical device companies with presence in the global market are also likely to conform to ISO 13485 and ISO 9000 quality standards with the help of a CRO quality control system.

The MasterControl integrated CRO quality control software suite facilitates FDA and ISO compliance by automating contract organizations’ quality process management. To accommodate the demanding needs of contract organizations, the software can be configured as per business requirements. It allows users to perform different operations through the easy-to-use interface and gives all employees a unified platform. It integrates different contract organizations quality assurance processes and connects different departments involved in the compliance initiative. With contract organizations emphasizing on quality control, the primary objective is to incorporate a solution that automates, streamlines, and effectively manages document control, change control, training control, audits, corrective/preventive action (CAPA), and customer complaints. This is where MasterControl provides contract organizations with a portal for managing all forms-based quality and business processes under a single Web-based platform.

Contract organizations understand the importance of FDA compliance, which is the reason MasterControl offers cutting-edge validation tools and services that will help ensure FDA compliance. The MasterControl Validation Solution consists of a continuum of products and services that address different levels of validation needs. Based on risk assessments, MasterControl’s contract organization (CRO) quality control software gives contract organizations the choice of either automated or manual validation services. The main intent of contract organizations is to lower validation cost. The MasterControl solution dramatically cuts the time involved in validating a CRO quality control system reduces risks of project implementation and makes it easier to validate software upgrades.

Contract organizations are conscious of intricacies revolving around handling massive amounts of paperwork pertaining to different procedures in the system. It gets tedious to keep updated documentation when processes are going through recursive updates and reviews that make it difficult for employees to be informed about the latest changes. Employees get confused about which document version to follow. It may take a while for a document to be routed to the appropriate personnel for review and by the time it actually gets approved, there may be a risk that employees have already used an outdated version of the document in performing a procedure. This is where MasterControl Documents, the core application in the MasterControl CRO quality management software suite, helps increase a contract organization’s quality assurance and empowers the quality team by automating task assignments/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. As documents are available within a single repository, the process of searching and retrieving is easy. MasterControl Documents integrates all quality processes such as change control, customer complaints, corrective/preventive action (CAPA), audits, etc., for a comprehensive solution.

Corrective and Preventive Action System

Corrective action and prevention action (CAPA) is a concept that helps companies monitor different business processes and escalate incidents that require rectification. This helps in identifying and tracking incidents that create anomalies and potential risks in the system. The MasterControl CAPA system interconnects different CRO quality assurance software subsystems and tracks incidents that can escalate into a corrective action. MasterControl CAPA’s “8D” process is specifically designed to guide the quality team through every step of CAPA implementation -- from identification of the problem to the action applied as a corrective measure. Since CAPA forms can be launched directly from another form (e.g., nonconformance or deviation report), the relevant data is automatically entered into the CAPA form which reduces manual data entry. This helps organizations eliminate errors that usually occur in manual transfer of information. MasterControl’s contract organization (CRO) quality control software is accessible to customers, vendors, and others outside the company through the internet. So users can submit customer complaint or other forms that could lead to CAPA. All these factors validate that the CAPA solution is truly at the root of CRO quality assurance system success.

Change Control

Contract organizations demand a faster turnaround in their business processes. This can be achieved by utilizing MasterControl Change Control, a solution that streamlines the entire change control procedure to bring quicker culmination to all operating procedures in the system. With MasterControl Change Control, risk of incorporating change at various levels is carefully assessed. Each change is classified either as low, medium, or high. Typically, a high-level change causes a great impact on the product and is likely to require regulatory filing. MasterControl's CRO quality control system provides customizable reports that show real-time status of change control tasks as well as of the entire quality system.

Training Management

With processes going through continuous changes, it is most likely that contract organizations also want to train employees about these alterations. Once training is complete, the next step is to test employees and evaluate how well they are acquainted with best business processes. MasterControl's CRO quality control training system automates assignment and monitoring of training tasks and grading of online exams. Training courses are sequenced, which implies that after a prerequisite course is complete; the next one is automatically launched. MasterControl's contract organizations quality assurance software provides a group sign-off feature for verifying training of large groups of employees. Contract organizations can integrate training management with the rest of the quality system. This way any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.

Nonconformance Automation Software

Since contract organizations conduct research and groundwork for medical and pharmaceutical companies, it is imperative for these organizations to streamline their business processes. An effective system is built on foundation of transparency and collaboration. This calls for a mechanism to identify non-conformities as soon as they arise in any procedure. MasterControl Nonconformance is a robust solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products. MasterControl’s contract organization (CRO) quality assurance solution provides a five-step process that connects all responsible personnel for effective and timely disposition of a nonconformance in a CRO quality assurance system. This way collaboration and direct communication between processes and employees helps in pointing out non-conformities and launching corrective actions. Depending on the size of your organization, you can select a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. Once a change is approved in the CRO quality control system, training for employees is automatically invoked.

Quality Audit Management

Auditing is the process through which contract organizations evaluate various departments, employees, documentation and business processes to validate and ensure a foolproof system. Through auditing, companies can identify weaker areas and concentrate on the improvement of respective processes. MasterControl’s CRO quality control audit solution automates, streamlines, and effectively manages the audit process. With advanced tracking capability, the audit process is carried out from the very beginning of a process to execution and completion. Our CRO quality control software offers best-practice forms for tracking basic audit information and audit findings. Many contract organizations schedule auditing on a repetitive basis so that the overall efficiency of business is increased. This objective is fulfilled with the automated scheduling of all recurring audit-related activities through MasterControl’s contract organization (CRO) quality assurance software. Moreover, top level managers are provided with advanced analytics and reporting capability. Through these features, managers get a detailed overview of the audit process in real time.

Customer Complaints Software

Since the main customers of contract organizations are medical and pharmaceutical companies, it is important to meet the demands of these customers without any delay. Otherwise the contract organization can lose potential sources of revenue to competitors. An effective system must consist of a mechanism through which customers are able to submit customers from anywhere. MasterControl Customer Complaints streamlines the complaint-handling process by providing customers with a web-based platform for filing complaints through the internet. This reduces the lifecycle from submission to resolution in the CRO quality assurance system. The software provides a three-step process through a pre-configured, multi-page form that starts with the processing of a customer complaint, automatically moving to internal investigation, and culminating with a resolution of the issue. MasterControl's CRO quality control software helps increase management oversight by providing advanced reporting capabilities. With these tools, management can decide and demonstrate appropriate controls to regulatory agencies.

Forms-Based Processes Automation

The majority of contract organizations have migrated to automated systems in order to save data electronically. This means that companies rely on entering automated data through electronic forms. Any error in manual data entry can create miscalculation for wrong hypothesis to become the basis of research. To avoid such a situation, MasterControl's contract organizations quality assurance process automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. Users are prompted with selected data to reduce data entry and avoid mistakes common in manual data entry. Our solution enables conversion of any form created in Microsoft Word, Excel, or PowerPoint to HTML. This way, users are already familiar with the look and feel of the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs within the CRO quality assurance software.

Electronic Submissions

MasterControl Submissions Gateway facilitates the electronic delivery of FDA applications such as IND, NDA, and BLA. The application provides control in assembling and tracking necessary documentation with appropriate templates to streamline the dossier-creation process. To accelerate submissions, MasterControl's CRO quality control system can be integrated with leading e-submission applications, connecting approved documents and forms-based content with the dossier assembly process.

Learn More About Contract Organizations (CRO) Quality Control andd Assurance

To learn more about the contract organizations quality control and CRO quality assurance, please feel free to contact a MasterControl representative.

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MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.

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